The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Mp Cs/cr Porous Femur/evolution Adaptive Cs And Ps Inserts.
| Device ID | K140735 |
| 510k Number | K140735 |
| Device Name: | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Caroline Fryar |
| Correspondent | Caroline Fryar MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-24 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192629082588 | K140735 | 000 |